FDA — authorised 26 March 1973
- Application: ANDA083102
- Marketing authorisation holder: WEST WARD
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Ergocalciferol Capsules in United States
FDA authorised Ergocalciferol Capsules on 26 March 1973 · 47 US adverse-event reports
Marketing authorisations
FDA — authorised 13 July 1973
- Application: ANDA080951
- Marketing authorisation holder: IMPAX LABS
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 September 1974
- Application: ANDA080825
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 October 1978
- Application: ANDA080704
- Marketing authorisation holder: BIONPHARMA
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA204276
- Marketing authorisation holder: PURACAP PHARM LLC
- Status: approved
FDA
- Application: ANDA084053
- Marketing authorisation holder: VITARINE
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA080956
- Marketing authorisation holder: EVERYLIFE
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA080747
- Marketing authorisation holder: CHASE CHEM
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 47
Most-reported reactions
- Diarrhoea — 8 reports (17.02%)
- Fatigue — 7 reports (14.89%)
- Nausea — 6 reports (12.77%)
- Dyspnoea — 5 reports (10.64%)
- Malaise — 4 reports (8.51%)
- Platelet Count Decreased — 4 reports (8.51%)
- Urticaria — 4 reports (8.51%)
- Abdominal Pain Upper — 3 reports (6.38%)
- Anaemia — 3 reports (6.38%)
- Constipation — 3 reports (6.38%)
Ergocalciferol Capsules in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Ergocalciferol Capsules approved in United States?
Yes. FDA authorised it on 26 March 1973; FDA authorised it on 13 July 1973; FDA authorised it on 26 September 1974.
Who is the marketing authorisation holder for Ergocalciferol Capsules in United States?
WEST WARD holds the US marketing authorisation.